ML18138A291

Shine Medical Technologies, Inc. - Submittal of Meeting Slides for the May 23 and 24, 2018 with NRC

ML18138A291
Person / Time
Site:	SHINE Medical Technologies
Issue date:	05/16/2018
From:	Jim Costedio SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML18138A272	List: ML18138A291
References
2018-SMT-0032
Download: ML18138A291 (28)

Text

THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR § 2.390 May 16, 2018 2018-SMT-0032 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington

, DC 20555 References

(1) U.S. Nuclear Regulatory Commission, "Pre-Application Meeting on SHINE Medical Technologies

, Inc. Licensing and Construction Planning," Meeting Notice, May 11, 2018 (ML18131A371)

Meeting Slides for the May 23 and 24, 2018 Public Meeting between SHINE Medical Technologies, Inc. and the NRC A meeting is scheduled between SHINE Medical Technologies, Inc. (SHINE) and the NRC staff (Reference

1) to discuss topics related to SHIN E's construction planning, licensing strategy, preliminary hazard and operability study results, and the structural design of the SHINE medical isotope production facility.

Enclosure 1 provides the SHINE meeting slides for the public portion of the discussion regarding construction planning.

Enclosure 2 provides the SHINE meeting slides for the non-public portion of the discussion regarding construction planning. In addition to proprietary information, Enclosure 2 contains security-related information which was identified utilizing the guidance contained in RIS 2005-31.

SHINE requests that the NRC withhold Enclosure 2, in its entirety, from public disclosure under 10 CFR § 2.390. Enclosure 3 provides the SHINE meeting slides for the discussion of the SHINE-proposed strategy for licensing the operation of the SHINE medical isotope production facility.

Enclosure 4 provides the SHINE meeting slides for the non-public discussion regarding the SHINE hazard analysis

approach, including a discussion of the results of preliminary hazards analyses.

In addition to proprietary information, Enclosure 4 contains security-related information which was identified utilizing the guidance contained in RIS 2005-31.

SHINE requests that the NRC withhold Enclosure 4, in its entirety, from public disclosure under 10 CFR § 2.390. (~I µfl{(_ Enclosures 2, 4, and 5 contain both proprietary and security-related information.

Withhold from public disclosure under 1 O CFR 2.390. Upon removal of Enclosures 2, 4, and 5, this letter is uncontrolled.

101 E. Milwaukee Street, Suite 600 I Janesville

, WI 53545 IP (608) 210-1060 IF (608) 210-2504 I www.shinemed.com Document Control Desk Page 2 THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR § 2.390 Enclosure 5 provides the SHINE meeting slides for the non-public discussion regarding the structural design of the SHINE medical isotope production facility. In addition to proprietary information, Enclosure 5 contains security-related information which was identified utilizing the guidance contained in RIS 2005-31.

SHINE requests that the NRG withhold Enclosure 5, in its entirety, from public disclosure under 1 O CFR § 2.390. Enclosure 6 provides an affidavit supporting the proprietary treatment of the SHINE proprietary information contained in Enclosures 2, 4, and 5, pursuant to 1 O CFR § 2.390. SHINE requests that the NRG withhold Enclosures 2, 4, and 5, in their entirety, from public disclosure under 1 O CFR § 2.390. Upon removal of Enclosures 2, 4, and 5, this letter is uncontrolled.

If you have any questions, please contact Mr. Jeff Bartelme, Licensing Manager, at 608/210-1735.

Very truly yours, J q:s Costedio

1. A:c": President of Regulatory Affairs and Quality SHINE Medical Technologies

, Inc. Docket No. 50-608 Enclosures cc: Project Manager, USNRC Supervisor, Radioactive Materials

Program, Wisconsin Division of Public Health (w/o Enclosures 2, 4, and 5) Enclosures 2, 4, and 5 contain both proprietary and security-related information

. Withhold from public disclosure under 1 O CFR 2.390. Upon removal of Enclosures 2, 4, and 5, this letter is uncontrolled.

ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC. MEETING SLIDES FOR THE MAY 23 AND 24, 2018 PUBLIC MEETING BETWEEN SHINE MEDICAL TECHNOLOGIES, INC. AND THE NRC CONSTRUCTION PLANNING (PUBLIC PORTION) 15 pages follow _J Construction Planning Eric Van Abel, Vice President Engineering Steve Miltenberger, Chief Operating Officer , Health. llluminated T~

Overview

• Initial construction scope and shared systems

• Current plans

• Configuration management

• Modifications to operating units/ impacts on to-be-constructed units

• Maintaining safety for construction during operations

• Content of design packages for N RC review

• Construction schedule SHINE Medical Technologies I 2 Initial Construction Scope and Shared Systems

• SHINE plans to initially construct the entire structure, but outfit two of the eight irradiation units, and the process and auxiliary systems that support these two units

• Irradiation Units 1 and 2 -TSV Off-gas Systems -Subcritical Assembly Systems -Primary Closed Loop Cooling Systems -Light Water Pool Systems -Neutron Driver Assembly Systems

• TSV Reactivity Protection System -Only as required for Irradiation Units 1 and 2

• Engineered Safety Features Actuation System (ESFAS) -Only as required for Irradiation Units 1 and 2 and installed RPF Systems

• Tritium Purification System -Only gloveboxes supporting Units 1 and 2 '\ SHINE Medical Technologies I 3 Site Plan ""' .8Ul.DINC

• =, -~ARY .CAS UNE .(I.CVATION

.EL£Ctfi'ICM..

.W,t.ltR UN( SHINE Medical Technolog ies I 4 Typical Facility Cross Section . 0 I 'b ,-..,......,...,...,..........,..--.......-~-.---..

I .lO : I"') SHINE Medical Technologies I 5 Configuration Management

• Requirements of ANSI/ANS 15.8, Section 3.1 O:

• Configuration Control:

Equipment shall be identified that requires configuration control.

Management is responsible for establishing and maintaining proper configuration and should authorize any changes to safety-related items. All configuration changes to safety-related items should be documented.

Before placing equipment into operation, the system shall be properly calibrated or checked, as appropriate, and any deficiencies in the equipment or the current configuration of the system documented.

This should also address methods for temporary modifications.

Reactor maintenance that requires a change in the system shall be documented

.

• For SHINE, safety-related items are QL-1

• Configuration management is implemented through a several procedures, which will expand as physical construction and procurement begins

• Final design activities are starting currently, which are covered by configuration control SHINE Medical Technologies I 6 Configuration Management

• Requirements of ANSI/ANS 15.8 are reflected in SHIN E's QAPD

• Section 2.1 -The Engineering Manager has functional areas of responsibility that include authority for day-to-day engineering support activities, design engineering, engineering configuration management

... modifications and their implementation, facility design configuration control ... The engineering manager is the design authority for the facility and is also responsible for maintaining the safety analysis.

• Section 3.10 -Equipment shall be identified that requires configuration control.

SHINE is responsible for establishing and maintaining proper configuration and should authorize any changes to safety-related items. All configuration changes to safety-related items should be documented.

Before placing equipment into operation, the system shall be properly calibrated or checked, as appropriate, and any deficiencies in the equipment or the current configuration of the system documented.

This should also address methods for temporary modifications.

SHINE facility maintenance that requires a change in the system shall be documented.

SHINE Medical Technologies I 7 Configuration Management

• Implementation of the requirements of SHIN E's QAPD are described in 1200-09-01, "Configuration Management"

• Ensures that consistency is maintained between the design requirements of SSCs, the physical configuration of SSCs in the SHINE facility, and inclusion of facility configuration information (FCI) of SSCs in controlled facility documents.

• Supports and interfaces with the following procedures and programs

-2200-01-01, "Issues Management"

• SHIN E's Corrective Action Program implementing procedure

-1200-01-02, "Calculations"

-1200-01-04, "Technical Reports"

-1200-01-08, "Drawings"

-1200-01-10, "Design Control"

-2000-01-07, "Records Management"

/ Design \ Requirement s What needs to be there I / Facility Physical Configuration Configuration Information What is .... Ilia------**

What we say is ther actually there "-_/ --. SHINE Medical Technologies I 8 Configuration Management

• SHINE is preparing final design packages

• Design packages begin with Design Criteria Documents (DCDs)

• Populated with all design calculations,

reports, and drawings that are sufficient to describe the design

• Packages are approved and released for construction

• First design packages will be for subgrade concrete and rebar

• Final design processes document the Design Requirements of configuration management

• With Phase 1 of construction, design packages will be issued for only extent of systems to be constructed

• Minimal additional features expected to be added to assist in construction during operation, documented in design packages

-Shield walls in pipe trenches to allow personnel access -Additional shielding between modules 4 and 5 in the hot cell -Separate piping runs for tritium system

• Changes during construction will be reviewed and approved by Engineering

• Completed construction packages are submitted and stored as Records

• SHIN E's design change procedure governs changes to existing designs SHINE Medical Technologies I 9 Modifications to Operating Units/ Impact on to-be Constructed Units

• All eight units will be described in FSAR, with Addendum describing configuration of Operating While Constructing

• Changes to facility (including operating units and yet-to-be constructed units) will be controlled by SHINE's 50.59 process

• SHINE will determine if NRC approval is needed prior to the change

• Design changes would be expected to be replicated on other, yet-to-be constructed units

• Example:

SHINE determines it is necessary to change TSV Off-gas System limiting flow rate with Units 1 and 2 operating

• Perform 50.59 evaluation on Units 1-8

• Due to independence and duplication of systems, results of 50.59 evaluation between units would not normally differ

• Results of the 50.59 process would be documented, and prior NRC approval would be sought if needed SHINE Medical Technologies I 10 Provisions for Constructing During Operations

• SHINE will implement a program to control construction activities during operations

• The "Operate While Constructing" program is a process that implements controls to ensure that the SHINE Safety Analysis remains valid during operations when part of the facility is still being constructed

• Necessary controls will be identified as part of the integrated safety analysis and implemented via SHINE processes and procedures, as appropriate SHINE Medical Technologies I 11 Provisions for Constructing During Operations

• Operate While Constructing Controls may include:

• Daily review and authorization of construction activities within the facility by SHINE Operations in accordance with a work control process

• Administrative controls on the proximity of construction activities to operating equipment

• Implementation of lock-out/tag-out processes to prevent interactions between operational and construction activities

• Limits on operational activities that are allowed to occur while construction activities are in progress

• Human factors controls (e.g., color coding, physical

barriers, flagging, etc.) to prevent construction or operational activities from occurring on incorrect equipment or in incorrect areas SHINE Medical Technologies I 12 Provisions for Constructing During Operations

• SHINE will implement additional administrative plans associated with the phased approach to operations

• The QA Program for design, construction, and pre-operational testing will continue simultaneously with the QA Program for the operations phase while construction activities are in progress.

• SHINE will develop and implement a system to plan and schedule system turnover as construction is completed

• Before system turnover, written procedures will be developed for controlling the transfer of SSCs and associated documentation

-These procedures will include checklists

, marked drawings, documentation lists, system status, and receipt control

• Major work activities performed by SHIN E's contractors will be identified and controlled

-SHINE will formally evaluate contractor performance, in accordance with the safety importance of the contracted activities SHINE Medical Technologies I 13 Design Packages

• SHINE Procedure 1200-01-10, "Design Control" addresses contents of Design Packages

• Design Packages are used to compile documents related to the original design and any modifications to the design

• Design Packages provide evidence that the design and design verification processes were performed in accordance with QA requirements and are collected, stored, and maintained within SHIN E's record's management system

• Design Packages include:

• Design Criteria Documents

• Drawings

• Calculations

• Technical reports

• Design review and verification documentation

• Draft FSAR markups to show changes from PSAR to FSAR SHINE Medical Technologies I 14 Construction Schedule

• In preparation for the NRC pre-construction review, the following scopes of work are planned to be available for review

• Geotechnical design

• Subgrade structure,

concrete, and rebar

• SHINE will be performing design on process and irradiation systems after construction starts on subgrade and above-grade structures

• Currently anticipated first concrete work is in October 2018

• Process system installation is anticipated starting 9 months following first concrete

• General sequence:

1. Sitework

7. Architectural

2. Subgrade concrete

8. Plumbing

3. Above-grade walls 9. HVAC 4. Bridge crane 10. Fire protection

5. Roof slabs and 11. Process equipment structural steel installation

6. Building envelope

12. Hot cell installation SHINE Medical Technologies I 15 ENCLOSURE 3 SHINE MEDICAL TECHNOLOGIES, INC. MEETING SLIDES FOR THE MAY 23 AND 24, 2018 PUBLIC MEETING BETWEEN SHINE MEDICAL TECHNOLOGIES, INC. AND THE NRC PROPOSED STRATEGY FOR LICENSING THE OPERATION OF THE SHINE MEDICAL ISOTOPE PRODUCTION FACILITY 6 pages follow Strategy for the Licensing of the SHINE Medical Isotope Production Facility Jeff Bartelme, Licensing Manager Health. llluminated T~

SHINE Operating License Application

-Application Request

• In accordance with the requirements of 10 CFR § 50.33(e),

SHINE intends on requesting a single Operating

License, to be issued pursuant to Section 103 of the , Atomic Energy Act of 1954 (as amended) and 10 CFR Part 50, for eight utilization facilities and one production facility

• SHINE intends on requesting an Operating License for the term of 30 years

• SHINE also intends on requesting licenses for the receipt, possession and use of byproduct material under 10 CFR Part 30, source material under 10 CFR Part 40, and special nuclear material under 10 CFR Part 70 SHINE Medical Technologies I 2 SHINE Operating License Application

-Application Content

• The SHINE Operating License Application will include the following elements:

• Final Safety Analysis Report (10 CFR § 50.34(b))

• Supplement to the SHINE Environmental Report (10 CFR § 51.53(b))

• Emergency Plan (10 CFR § 50.34(b)(6)(v))

• Operator Requalification Program (10 CFR § 50.34(b)(8))

• Technical Specifications (10 CFR § 50.34(b)(6)(vi))

• Quality Assurance Program Description (10 CFR § 50.34(b)(6)(ii))

• Decommissioning Report (10 CFR § 50.33(k)(1))

• Physical Security Plan (10 CFR § 73.67(c)(1

))

• Material Control and Accountability Program (10 CFR § 74.41)

• Integrated Safety Analysis (ISA) Summary SHINE Medical Technologies I 3 Structure of the Final Safety Analysis Report

• The SHINE FSAR (Chapters 1-18) will describe and analyze the full SHINE facility, including eight irradiation units, the complete supercell, and the support systems required to support full operation of the facility

• As discussed

earlier, irradiation facility and the radioisotope production facility structures,

systems, and components (SSCs) will be installed in phases

• SHINE will provide an addendum to the FSAR describing each phase of SHIN E's phased approach to full operation

• For each phase described in the addendum, SHINE will provide:

• A description of the SSCs installed to support operation of the subject phase;

• A basis for the partial SSC installation;

• An analysis of the impact of the partial SSC installation on the Integrated Safety Analysis; and

• Administrative controls which will be in place

• SHINE anticipates the addendum following similar format and content guidance as the FSAR (i.e., each phase will include 18 sections, with comparisons to the full facility description/analysis provided in Chapters 1-18 of the FSAR) SHINE Medical Technologies I 4 Determination of Substantially Complete

• Upon substantial completion of the construction of SSCs required to support operation of a subject phase (as described in the FSAR addendum),

SHINE will provide notification to the NRC to initiate the operational readiness inspection (IP 69022)

• At this point, the NRC will be able to complete the IP 69022 inspection objectives for the subject operational phase, including:

-Evaluating the status of construction and preoperational testing of the phase, including identification of areas where construction or preoperational testing is incomplete

-Evaluating SHIN E's readiness to perform activities during operation of the phase -Evaluating the status of open items and their significance

• NRC completion of IP 69022 for a subject operational phase supports the required findings of 10 CFR § 50.57(a),

including the determination construction of the subject operational phase has been substantially completed, such that the NRC may

• authorize operation of the subject operational phase SHINE Medical Technologies I 5 Consideration of Phased Approach on Single Operating License

• SHINE intends on requesting the NRC issue a single Operating License for the full facility operation (i.e., eight utilization facilities and one production facility),

with appropriate license conditions, at the time of the authorization to operate the initial phase of SHIN E's operations

• The NRC has recently used a similar licensing approach for authorizing phased operation at Part 70 enrichment facilities

-Louisiana Energy Services, LLC -URENCO USA Facility (License No. SNM-2010)

-AREVA Nuclear Materials, LLC -Eagle Rock Enrichment Facility (License No. SNM-2015)

• To support SHIN E's phased approach to full facility operation, and to ensure SHINE does not operate subsequent utilization facilities or additional processing capacity of the production facility prior to the appropriate NRC authorization, SHINE proposes the NRC condition the initial issuance of the SH IN E Operating License as follows: "Operation of subsequent utilization facilities or additional processing capacity of the production faci-lity shall not occur until the Commission completes a review to confirm the facility will be operated safely and in accordance with the requirements of the license." SHINE Medical Technologies I 6 ENCLOSURE 6 SHINE MEDICAL TECHNOLOGIES, INC. MEETING SLIDES FOR THE MAY 23 AND 24, 2018 PUBLIC MEETING BETWEEN SHINE MEDICAL TECHNOLOGIES, INC. AND THE NRC AFFIDAVIT OF JAMES COSTEDIO 2 pages follow AFFIDAVIT OF JAMES COSTEDIO STATE OF WISCONSIN

) ) ss. COUNTY OF ROCK ) I, James Costedio, Vice President of Regulatory Affairs and Quality of SHINE Medical Technologies, Inc. (SHINE),

do hereby affirm and state: 1. I am authorized to execute this affidavit on behalf of SHINE. I am authorized to review information submitted to or discussed with the Nuclear Regulatory Commission (NRC) and apply for the withholding of information from public disclosure

. The purpose of this affidavit is to provide the information required by 1 O CFR 2.390(b) in support of SHIN E's request for proprietary treatment of certain confidential commercial and financial information submitted in the public meeting slides provide by letter 2018-SMT-0032 with enclosures.

SHINE requests that the confidential information contained in Enclosures 2, 4, and 5 be withheld from public disclosure in their entirety.

2. I have knowledge of the criteria used by SHINE in designating information as sensitive

, proprietary

, or confidential.

3. Pursuant to the provisions of paragraph (a)(4) of 1 O CFR 2.390, the following is furnished for consideration by the NRC in determining whether the information sought to be withheld from public disclosure should be withheld. a. The information sought to be withheld from public disclosure contained in Enclosures 2, 4, and 5 of 2018-SMT-0032 is owned by SHINE, its affiliates

, or third parties to whom SHINE has an obligation to maintain its confidentiality

. This information is and has been held in confidence by SHINE. b. The information sought to be protected in Enclosures 2, 4, and 5 of 2018-SMT-0032 is not available to the public to the best of my knowledge and belief. 1

c. The information contained in Enclosures 2, 4, and 5 of 2018-SMT-0032 is of the type that is customarily held in confidence by SHINE, and there is a rational basis for doing so. The information that SHINE is requesting to be withheld from public disclosure includes trade secret, commercial financial information

, commercial information, or information that is subject to export controls. SHINE limits access to these elements to those with a "need to know," and subject to maintaining confidentiality

. d. The proprietary information sought to be withheld from public disclosure in Enclosures 2, 4, and 5 of 2018-SMT-0032 includes, but is not limited to: structural configuration

, primary and supporting systems of the medical isotope production facility, process and system locations, and process details.

This would include information regarding the types, quantities, and locations of materials stored on site as would be referenced in facility configuration drawings.

Public disclosure of the information in Enclosures 2, 4, and 5 of 2018-SMT-0032 would create substantial harm to SHINE because it would reveal trade secrets owned by SHINE, its affiliates

, or third parties to whom SHINE has an obligation to maintain its confidentiality

. e. Public disclosure of the information in Enclosures 2, 4, and 5 of 2018-SMT-0032 would create substantial harm to SHINE because it would reveal valuable business information regarding SHINE's competitive expectations

, assumptions

, processes

, and current position. Its use by a competitor could substantially improve their competitive position in the design, manufacture,

shipment, installation

, assurance of quality, or licensing of a similar product.

f. The information contained in Enclosures 2, 4, and 5 of 2018-SMT-0032 is transmitted to the NRC in confidence and under the provisions of 10 CFR 2.390; it is to be received in confidence by the NRC. The information is properly marked. I declare under the penalty of perjury that the foregoing is true and correct.

Executed on May 15, 2018. Vice President of Regulatory Affairs and Quality SHINE Medical Technologies

, Inc. 2